Kornimate/medical-research-clean huggingface dataset:
a feasibility study of a 12 week training intervention with patients with type 2 diabetes and mody in greenland

Conditions: Type 2 Diabetes; MODY

Summary: the goal of this study is to investigate to what extent a 12-week training course for people with type 2 diabetes mellitus (t2dm) or mody can be conducted in a clinical context with clinically relevant improvements in cardiometabolic risk factors and quality of life? the main questions it aims to answer are: 1. to investigate the feasibility of supervised training for people with t2dm or mody in a clinical context in greenland. 2. to investigate evidence of the effect of combined aerobic and strength training on cardiometabolic risk factors and mental well-being. 3. to investigate the signs of efficacy and different interactions with the type of disease.

globally, type 2 diabetes mellitus (t2dm) is a major public health issue. this is also the fact in greenland, the biggest island in the world. twice as many greenlanders as danes have diabetes, and this is due to both lifestyle and genes. it is estimated that 7% of t2dm patients in greenland have maturity onset diabetes of the young (mody), which is hereditary and rare elsewhere. exercise improves blood sugar control in t2dm, reduces cardiovascular risk factors such as hypertension and dyslipidemia, contributes to weight loss and improves fitness and well-being. less is known of how people with mody responds to exercise. today, the greenlandic health care system only offers supervised physical training to people with osteoarthritis in two towns in greenland, but in the future, they would like to offer supervised physical training to people with other conditions too. relevance: as mentioned above, this study aims to evaluate the feasibility of a 12-week supervised physical training intervention for people with t2dm or mody and to investigate signs of efficacy and different interactions with the type of disease.

Eligibility criteria:
inclusion criteria: * type 2 diabetes or mody * living in the capital in greenland, nuuk exclusion criteria: * severe heart disease
intelligent physical exercise training (ipet) in the offshore wind industry: a feasibility study

Conditions: Physical Capacity

Summary: a study to assess the feasibility of a 12-week exercise intervention aiming at improving the physical capacity and health of wind technicians. it was hypothesized that the intervention would be well-accepted by workers and show high compliance and clinically relevant increases in physical capacities among wind technicians.

one-arm feasibility study, including a within-group control period, to test compliance, practicality, acceptability and preliminary efficacy of implementing intelligent physical exercise training (ipet) in the offshore wind industry among wind technicians. the exercise program was individually tailored based on the findings from a pre-screening health and physical capacity check and the occupational demands of wind technicians. primary outcomes were compliance, adherence, adverse events and satisfaction. secondary outcomes were physical capacity and musculoskeletal disorders. prior to the feasibility study, intervention mapping was used as a theoretical tool to plan the intervention. the intervention consisted of 1-hour weekly individually tailored exercise training during working hours. exercise sessions were supervised during the first 8 weeks of the intervention and self-administered the last 4 weeks. the design included a 6 month control period prior to initiating the intervention. thus, included technicians (n:24) had their health and physical capacity assessed 6 months prior to intervention start (t1), at intervention start (t2) and 12 weeks after (t3) and they responded to questionnaires on musculoskeletal symptoms at all three occasions. further, a questionnaire customized to the specific intervention was distributed to all technicians 8 weeks after intervention start to assess satisfaction with the exercise program.

Eligibility criteria:
inclusion criteria: wind technician valid fitness and medical certificate adult \>18 years exclusion criteria: hypertensive with blood pressure above 165 mmhg systolic and 105 mmhg diastolic. severe pain would exclude technicians from strength measurements

Keywords: physical capacity feasibility workplace exercise
examining the effectiveness of wysa for worry program

Conditions: Anxiety

Summary: the goal of this randomized controlled trial is to test for the effectiveness of wysa's worry computerized cognitive behaviour therapy (ccbt) program (a digital mental health intervention) in comparison to a digital app that offers psychoeducation to patients who have mild to moderate symptoms of anxiety.

people dealing with worry can receive augmented support from digital mental health interventions. the intervention being tested in this study is wysa's worry ccbt program. its outcomes will be compared to a randomized, controlled arm that offers psychoeducation. for the purpose of this study participants will be recruited through different online channels and will be randomly assigned to either the intervention or control group. regardless of their assignment they will be completing weekly standardized assessments examining their symptoms of anxiety and depression, and examining any improvement.

Eligibility criteria:
inclusion criteria: * the inclusion criteria for the study is as follows: * patients who are at least 18 years of age. * patients who have mild to moderate symptoms of anxiety (scores: 5-15, according to gad-7). * patients who are not already engaged in psychological therapy and not intending to start psychological therapy in the next eight weeks. * patients who haven't used any dmhi (digital mental health interventions) in the last 6 months. * patients without risk of suicidal ideation and behaviour. * patients who are capable of reading and understanding english and have provided written or verbal informed consent to participate. * patients who own and use a smartphone with functional audio. exclusion criteria: * patients who are at an increased risk of suicide. * patients with diagnosis of or receiving treatment for alcohol/substance use disorder. * patients who've had their psychiatric medication or dose changed in the last 1 month. * patients who suffer from severe anxiety * patients with diagnosis of or receiving treatment for an active state of psychosis.

Keywords: worry anxiety digital mental health
fluocinolone acetonide intravitreal inserts in geographic atrophy

Conditions: Age-Related Macular Degeneration

Summary: this study will compare the safety and efficacy of medidur fa treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to amd.

each patient received a sham injection in one eye and active treatment in the other eye. the eye receiving active treatment was selected based on a randomization schedule.

Eligibility criteria:
inclusion criteria: * clinical diagnosis bilateral ga secondary to amd of ≥ 0.5 and ≤ 7 mps disc areas * males and non-pregnant females 55 years old or older exclusion criteria: * ga secondary to any condition other than amd in either eye * history of or current cnv in either eye or the need for anti-angiogenic therapy * glaucoma or ocular hypertension (iop \> 21 mmhg or concurrent therapy at screening with iop-lowering agents) in either eye * treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye * any change in systemic steroid therapy within 3 months of screening * history of vitrectomy in either eye * any ocular surgery within 12 weeks of screening in either eye

Keywords: amd age-related macular degeneration geographic atrophy ga
observatory on cow's milk protein allergy

Conditions: Food Allergy

Summary: the purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed the pepticate® syneo® replacement formula as soon as they were diagnosed. the pepticate® syneo® product is an advanced protein hydrolyzate, food type intended for special medical purposes. this is a product already available on the market.

this is a prospective, observational, descriptive, longitudinal, multicentric study aimed at describing a cohort of infants with a recently suspected or confirmed allergy to cow's milk protein, who were treated in outpatient and inpatient settings. the recruitment of patients eligible for this observatory will be done via community medicine (private practices of pediatricians and general practitioners) as well as in hospitals throughout france.

Eligibility criteria:
inclusion criteria: * infants up to and including 8 months (up to 8 months and 29 days). * initial diagnosis of allergy to cow proteins, suspected (clinical presumption) or confirmed. * prescription of the substitution formula pepticate® syneo, according to the doctor's judgement, whether the child is under mixed or weaned breastfeeding. * authorisation from a legal representative for the child to take part in the observatory and to collect personal information about the child and the family. * membership of the social security system. exclusion criteria: * infants who have already received partial or total replacement infant formula (regardless of the type of infant formula). * contraindication to the use of symbiotics (short small intestine, parenteral nutrition, post-pyloric feeding, central venous catheter) due to the use of pepticate® syneo®. * diagnosis of severe cow protein allergy requiring an infant amino acid formula from the outset. * the child's legal guardian is protected (under legal protection, or deprived of liberty by judicial or administrative decision). * the legal representative is unable to understand the study protocol.
topical application of tranexamic acid reduces postoperative blood loss in total hip arthroplasty

Conditions: Hip Replacement; Postoperative Hemorrhage

Summary: tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. most trials in orthopedic surgery have been conducted intravenously in arthroplasty, hip fracture and spine surgeries. this study would aim to see the effect of topical use of tranexamic acid in reduction of blood loss and transfusions for total hip arthroplasty


Eligibility criteria:
inclusion criteria: * patient who are to undergo elective total hip arthroplasty. * must be primary arthroplasty. * must be single-side arthroplasty. * must be older than 18 years. exclusion criteria: * cemented arthroplasty. * patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia . * patients with known coagulopathy (aptt or pt outside normal range pre-operatively). * patients who have a past medical history of thrombi-embolism at any time. * patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit \<24%). * patients with documented dvt or pe at screening or in past three months. * patients having known hypersensitivity to tranexamic acid or any other. constituent of the product. * patients with any associated major illness (e.g., severe cardiac \[new york heart association class iii or iv\] or respiratory disease). * anticoagulants (other than lmwh or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week. * jehovah's witnesses, or any other group of patients with ethical objections to receiving blood products.

Keywords: tranexamic acid
cisplatin, paclitaxel, and gemcitabine in treating patients with progressive unresectable regional or metastatic bladder cancer

Conditions: Bladder Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining cisplatin, paclitaxel, and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer.

objectives: * determine the efficacy and toxicity of cisplatin, paclitaxel, and gemcitabine in patients with progressive unresectable regional or metastatic transitional cell carcinoma of the bladder. * determine the progression free survival of these patients treated with this regimen. outline: this is a multicenter study. patients receive gemcitabine iv over 30 minutes on days 1 and 8, and cisplatin iv over 1 hour and paclitaxel iv over 3 hours on day 1. treatment repeats every 3 weeks for 6 courses. patients are followed every 3 months until disease progression. projected accrual: a total of 39 patients will be accrued for this study within 18 months.

Eligibility criteria:
disease characteristics: * histologically proven progressive unresectable regional or metastatic transitional cell carcinoma of the bladder * measurable disease by ct or mri scan * greater than 10 mm patient characteristics: age: * 18 to 75 performance status: * who 0-2 life expectancy: * at least 3 months hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 150,000/mm\^3 hepatic: * not specified renal: * creatinine less than 1.36 mg/dl cardiovascular: * no uncontrolled cardiac disease * no severe cardiac arrhythmias other: * not pregnant or nursing * no other prior malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: * prior intravesical immunotherapy for superficial disease allowed * no prior systemic biologic response modifier therapy for advanced disease chemotherapy: * prior intravesical chemotherapy for superficial disease allowed * no prior systemic chemotherapy for advanced disease endocrine therapy: * not specified radiotherapy: * prior radiotherapy allowed surgery: * no prior surgery

Keywords: stage iii bladder cancer stage iv bladder cancer transitional cell carcinoma of the bladder
efficacy and safety of hcp1102 capsule in patients with perennial allergic rhinitis

Conditions: Perennial Allergic Rhinitis

Summary: efficacy and safety of hcp1102 in patients with perennial allergic rhinitis : a randomized, double-blind, active-controlled, multicenter phase 3 clinical trial


Eligibility criteria:
inclusion criteria: * patients with at least 2 years history of par prior to the study * positive results of skin prick test * patients who provided a signed written informed consent form * patients who are able and willing to complete subject diaries * patients who agree to maintain consistency in their surroundings throughout the study period exclusion criteria: * patients also with non-allergic rhinitis with different causes. * patients with severe asthma. * history of acute • chronic sinusitis within 1 month of visit 1 * history of intranasal surgeries within 3 months of visit 1 * initiation of immunotherapy or dose modification within 1 month prior to visit 1 * upper respiratory infections including cold and systemic infections within 3 weeks of visit 1. * chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug.
surveillance, prevention and treatment of intra-abdominal hypertension and abdominal compartment syndrome

Conditions: Intra-Abdominal Hypertension; Abdominal Compartment Syndrome

Summary: this study evaluates the efficacy of intensive surveillance, prevention and treatment of intra-abdominal hypertension in icu patients. in the first two months patients will be screened and undergo usual care. in the following 10-months patients will have more intensive screening and active measures towards prevention and treatment according to best practices.

elevated intra-abdominal pressures or intra-abdominal hypertension (iah) has been shown to be common in all intensive care unit (icu) patients (upwards of 50%) and has been suggested as the missing link in multi-organ dysfunction, and subsequently icu mortality. despite guidelines advocating prevention and surveillance of iah, adherence remains low in most icus across north america and europe. the creation of the world society of the abdominal compartment syndrome (wsacs) in 2004 improved the recognition of iah/acs by intensivists. the first consensus guidelines from the wsacs were released in 2006, followed by a 2013 update. additionally, clinical practice guidelines and recommendations for research were released in 2007 and 2009 respectively, which attempted to standardize research methods and reporting. unfortunately, even in the 2013 guidelines only weak recommendations (by grade methodology) could be made regarding the efficacy of surveillance and treatment of iah/acs, citing a lack of high quality interventional trials. the investigator's study aims to assess the feasibility of a larger multi-center interventional trial to investigate the efficacy of aggressive screening, prevention and treatment of iah in icu patients.

Eligibility criteria:
inclusion criteria: * adults (\> 18 years of age) * admitted to intensive care unit * bladder catheter in-situ exclusion criteria: * death prior to first iap pressure measurement * pregnancy * expected icu discharge within 24 hours * organ donor * clinical care team or patient/substitute decision maker declines to enroll patient
urinary antigen test for stretococcus pneumoniae serotype prevalence in community acquired pneumonia

Conditions: Pneumonia

Summary: this is an epidemiology study for the prevalence and serotypes of pneumococcus pneumoniae in hospitalized patients with community acquired pneumonia (cap). the serotypes of the pneumococcus pneumoniae will be determined by a urinary antigen assay


Eligibility criteria:
inclusion criteria: admitted with signs and symptoms suggestive of pneumonia which include one or more of the followings: 1. fever 2. cxr changes with consolidation, increased alveolar shadowing or hazziness 3. respiratory symptoms like increase shortness of breath, cough with sputum raised inflammatory markers suggesting of bacterial infection with either increased white cell count or c-reactive protein, or both exclusion criteria: * nosocomial pneumonia which is acquired \>= 48 hours after hospital admission. pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.
comparison of clinical outcomes and performance of total knee replacement patients before and after surgery

Conditions: Degenerative Joint Disease; Osteoarthritis; Knee Injury, Trauma; Connective Tissue Disorder; Pain; Loss of Function

Summary: this study is to determine the relevancy of clinical scales for outcome measures as compared to flexion angle and other gait measures. clinical outcomes measures in the form of the knee society score and the womac score will be obtained from patients. gait data will also be obtained from total knee replacement (tkr) patients at pre-operative and post-operative times. gait data will be measured on unaffected normal controls as a second baseline. the hypothesis is that the subjects clinical outcome measures do not accurately reflect gait dependent outcomes amd functional performance of the total knee replacement.

patients scheduled to undergo unilateral total knee replacement (tkr) surgery will be the subjects of the study. a control group of healthy volunteers, will serve as a control group. the control group will be matched as close as possible by age and gender to the tkr group. both pre and post-operative (3 weeks, 6, 9 and 12 months follow-up) measurements will be performed on the tkr group. a intelligent device for energy expenditure and activity (ideea) will be used to record body motion, the sensors for the ideea device will be placed on the patient and secured with adhesive tape(if not allergic) once the ideea device is properly placed on the patient, measuring and calibrating can start. the patient will be required to perform tasks, walking at a normal pace for approximately 100 feet on a level surface, walk up and down moderate incline ramp, climb stairs 7 to 8 steps, sit and rise from two chairs. parameters will be measured on each subject, knee flexion angle( walking, stair climbing and sitting), velocity ( walking and stair climbing), stride length (walking), energy (walking, stair climbing, and sitting), other parameters will be added as needed.

Eligibility criteria:
inclusion criteria: * healthy * needs unilateral total knee replacement exclusion criteria: * active infection * autoimmune disease/ parkinson's disease * hiv * psychosocial disorders that would preclude accurate evaluation or substance abuse * allergic to * pregnant * active malignancy

Keywords: total knee replacement
androgen regulation of priapism in sickle cell disease

Conditions: Priapism; Sickle Cell Disease; Hypogonadism

Summary: it is believed that when androgen (testosterone) levels are below normal there is a disturbance of normal bodily functioning that is associated with priapism in some men. conversely, it is believed that testosterone replacement will improve the condition of priapism when the testosterone levels are brought to normal. in turn, this will also improve psychological well being in men with sickle cell disease (scd).

the central hypothesis of this proposal is that a decline in androgen levels results in decreased action and contributes to the molecular derangements associated with priapism. optimizing androgen status may promote regulatory molecular mechanisms that protect against priapism. this clinical trial will investigate the potential benefit of precise testosterone replacement for ameliorating priapism and improving psychological well-being in hypogonadal men with scd. this clinical trial aims to evaluate the efficacy of testosterone replacement therapy on the frequency of recurrent priapism in patients with scd. the sub-hypothesis that testosterone (t) replacement to achieve serum t concentrations at a target range reduces recurrent priapism will be tested. this aim will involve subjective and objective assessments of priapism occurrences and erectile ability including priapism inventory instruments, standardized questionnaires of erectile function (ef) and quality of life, and rigiscan™ erection monitoring in a 3.5-month pilot investigation.

Eligibility criteria:
inclusion criteria: * ages 18-50 * history of scd * episodes of prolonged penile erection in the absence of sexual interest or desire, with an average frequency of at least twice weekly, when averaged over the previous four weeks * serum testosterone level below 550 ng/dl * ability to provide informed consent exclusion criteria: * alcohol use exceeding two standard drinks daily * prostate conditions including prostate specific antigen (psa) elevation (\>2.5 ng/ml) * known sleep apnea * known cirrhosis * enlarged and painful male breasts

Keywords: priapism sickle cell disease testosterone androgen deficiency